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利用者名:
UMIN ID:

試験進捗状況 限定募集中/Enrolling by invitation
UMIN試験ID UMIN000020784
受付番号 R000023991
科学的試験名 抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study)
一般公開日(本登録希望日) 2016/01/29
最終更新日 2016/07/15

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study) Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
一般向け試験名略称/Acronym 抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study) QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
科学的試験名/Scientific Title 抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study) Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
科学的試験名略称/Scientific Title:Acronym 抗癌剤治療に伴う副作用とQOL・身体負担についての臨床研究(QL-GCU study) QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 尿路上皮癌 urothelial cancer
疾患区分1/Classification by specialty
泌尿器科学/Urology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 The aim of the present prospective study was to compare the quality of life, safety and efficacy of gemcitabine/cisplatin or gemcitabine/carboplatin therapy in patients with advanced urothelial cancer. The aim of the present prospective study was to compare the quality of life, safety and efficacy of gemcitabine/cisplatin or gemcitabine/carboplatin therapy in patients with advanced urothelial cancer.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy. Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy.
副次アウトカム評価項目/Key secondary outcomes Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety. Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety.

基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
90 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria Patients must have histologic proof of urothelial cancer.
Patients with primary tumors arising in the upper urinary tract (ureter or renal pelvis), bladder or urethra are eligible
Patients must have an evaluation in the department of urology.
ECOG performance status (PS) of 0, 1 or 2 if of recent onset and due entirely to the cancer and not due to comorbidity (especially if the compromised performance status is related to uncontrolled pain which is expected to be rapidly reversible when therapy starts)
Normal liver function (Transaminase (AST or ALT) </= 3 * the ULN, Conjugated bilirubin </= 1.5 mg/dl (or total bilirubin </= 2.5 mg/dl)
No severe chronic heart failure
Not severe renal dysfunction (eGFR < 30 ml/min/1.72m2)
Patients with other malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response in the cystectomy specimen. The expected survival from the prior malignancy should reliably be > 4 years to be eligible for this study.
Patients must be >/= 20 years of age.
Patients must have histologic proof of urothelial cancer.
Patients with primary tumors arising in the upper urinary tract (ureter or renal pelvis), bladder or urethra are eligible
Patients must have an evaluation in the department of urology.
ECOG performance status (PS) of 0, 1 or 2 if of recent onset and due entirely to the cancer and not due to comorbidity (especially if the compromised performance status is related to uncontrolled pain which is expected to be rapidly reversible when therapy starts)
Normal liver function (Transaminase (AST or ALT) </= 3 * the ULN, Conjugated bilirubin </= 1.5 mg/dl (or total bilirubin </= 2.5 mg/dl)
No severe chronic heart failure
Not severe renal dysfunction (eGFR < 30 ml/min/1.72m2)
Patients with other malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response in the cystectomy specimen. The expected survival from the prior malignancy should reliably be > 4 years to be eligible for this study.
Patients must be >/= 20 years of age.
除外基準/Key exclusion criteria Patients must not have current, recent (within 3 weeks), or planned participation with other experimental medication clinical trials.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
History of stroke or transient ischemic attack within 6 months prior to study enrollment.
Clinically significant peripheral vascular disease (e.g., aortic aneurysm, aortic dissection).
Symptomatic peripheral vascular disease.
Evidence of bleeding diathesis or coagulopathy.
Known history of central nervous system or brain metastases.
Lactating women.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to therapy. Patients with Crohn's disease will be excluded.
Serious, non-healing wound, ulcer, or bone fracture.
Other malignancies with severe prognosis (overall survival expected within 1 year)
Inability to comply with study and/or follow-up procedures, or sign informed consent.
Patients who are not candidates, or are unwilling to undergo systemic chemotherapy.
Patients with fluid collections (such as ascites, or pleural effusions) are not eligible for therapy.
Know hypersensitivity to any component of gemcitabine, cisplatin, or carboplatin
Patients must not have current, recent (within 3 weeks), or planned participation with other experimental medication clinical trials.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
History of stroke or transient ischemic attack within 6 months prior to study enrollment.
Clinically significant peripheral vascular disease (e.g., aortic aneurysm, aortic dissection).
Symptomatic peripheral vascular disease.
Evidence of bleeding diathesis or coagulopathy.
Known history of central nervous system or brain metastases.
Lactating women.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to therapy. Patients with Crohn's disease will be excluded.
Serious, non-healing wound, ulcer, or bone fracture.
Other malignancies with severe prognosis (overall survival expected within 1 year)
Inability to comply with study and/or follow-up procedures, or sign informed consent.
Patients who are not candidates, or are unwilling to undergo systemic chemotherapy.
Patients with fluid collections (such as ascites, or pleural effusions) are not eligible for therapy.
Know hypersensitivity to any component of gemcitabine, cisplatin, or carboplatin
目標参加者数/Target sample size 200

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム
畠山真吾

ミドルネーム
Shingo Hatakeyama
所属組織/Organization 弘前大学 大学院医学研究科 Hirosaki University Graduate School of Medicine
所属部署/Division name 泌尿器科 Urology
郵便番号/Zip code
住所/Address 青森県弘前市在府町5 5 Zaifu-chou, Hirosaki, Japan
電話/TEL +81172395091
Email/Email shingorilla2@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム
畠山真吾

ミドルネーム
Shingo Hatakeyama
組織名/Organization 弘前大学 大学院医学研究科 Hirosaki University Graduate School of Medicine
部署名/Division name 泌尿器科 Urology
郵便番号/Zip code
住所/Address 青森県弘前市在府町5 5 Zaifu-chou, Hirosaki, Japan
電話/TEL +81172395091
試験のホームページURL/Homepage URL
Email/Email shingorilla2@gmail.com

実施責任組織/Sponsor
機関名/Institute 弘前大学 Hirosaki University Graduate School of Medicine
機関名/Institute
(機関選択不可の場合)
弘前大学 大学院医学研究科
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Oyokyo Kidney Research Institute
機関名/Organization
(機関選択不可の場合)
鷹揚郷腎研究所
組織名/Division
組織の区分/Category of Funding Organization その他/Other
研究費拠出国/Nationality of Funding Organization JAPAN JAPAN

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2016 01 29

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 限定募集中/Enrolling by invitation
プロトコル確定日/Date of protocol fixation
2013 04 01
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2013 06 01
フォロー終了(予定)日/Last follow-up date
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information 観察研究
研究デザイン(コホート研究)
対象者の募集方法(2013年6月-2018月6月までに当施設を受診した患者で選択基準に合致した患者)
測定する項目:QLQ-C30によるQOL測定(化学療法の1コース目:Day1, 3, 8, 15,2コース目Day1, 3, 15)、副作用評価(CTCAEに準ずる)、治療効果(RECISTに準ずる)、体重減少、腎機能障害、抗腫瘍免疫(NK細胞、T細胞数)など
Observational study
Design: Cohort study
Recruitment period: June 2013 to June 2018, at Hirosaki University Hospital, who met the inclusion criteria.
We compared quality of life (QOL) using QLQ-C30 questionnaire at day 1, 3, and 15 in each cycle. Primary endpoint is the QOL differences between before and after 2 courses of neoadjuvant chemotherapy. Secondary endpoints included tumor response (RECIST v1.1), rate of weight loss, renal faction decline, toxicity and safety, and changes of anti-tumor immune cells (NK cell or T cells).

管理情報/Management information
登録日時/Registered date
2016 01 28
最終更新日/Last modified on
2016 07 15


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000023991
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023991

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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